AMPLATZER Duct Occluder II Additional Sizes

Condition: Patent ductus arteriosus

Eligibility

Key Inclusion Criteria

  • Diagnosis of a PDA
  • PDA ≤4 mm in diameter
  • PDA ≥3 mm in length

Key Exclusion Criteria

  • Weight <700 grams at time of the procedure
  • Gestational age <24 weeks at birth
  • Less than three days old at time of procedure

Full Study Name

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study (IRB no. 46941)

Summary

The purpose of this study is to evaluate whether an investigational medical device called the AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) is safe and effective for the treatment of patent ductus arteriosus (PDA). The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs. Within the first few days after a baby's first breath, the ductus arteriosus should close permanently. If it does not close, it remains open and is known as a PDA. The study will focus only on the ADO II AS device in patients with a PDA of less than 4 mm in diameter.

Financial disclosure: Evan Zahn, MD, the principal investigator, receives payment from the company sponsoring this study. He receives consulting fees, honoraria, gifts or "in kind" payments.


Principal Investigator

Evan Zahn, MD

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